Cleared Traditional

K922729 - SPARTA WET DRESSING, SODIUM CHLORIDE

K922729 · Sparta Surgical Corp. · General & Plastic Surgery device
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Nov 1992
Decision
171d
Days
-
Risk

K922729 is an FDA 510(k) clearance for the SPARTA WET DRESSING, SODIUM CHLORIDE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Sparta Surgical Corp. (Hammonton, US). The FDA issued a Cleared decision on November 23, 1992 after a review of 171 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Sparta Surgical Corp. devices

FDA 510(k) Submission Details - K922729

510(k) Number K922729 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 05, 1992
Decision Date November 23, 1992
Days to Decision 171 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 115d · This submission: 171d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 283
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K922729.
SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER)
K932676 · Polymedica Industries, Inc. · Dec 1993
SALINE WET DRESSING- STERILE
K934258 · Trinity Laboratories, Inc. · Nov 1993
DERMAGRAN WOUND DRESSING
K924754 · Derma Sciences, Inc. · May 1993
INCARE HOT/ICE ABSORBENT INTERFACE
K913035 · Hollister, Inc. · Sep 1991
DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK
K904852 · Convatec, A Division of E.R. Squibb & Sons · Jan 1991
WOUND TREATMENT KIT
K901109 · Orion Life Systems, Inc. · Jun 1990